Trial · NCT03044353
Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698
NCT03044353, Phase 2, Terminated, GlaxoSmithKline; results first posted 2019-10-16
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698. Trials, record NCT03044353. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03044353
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698
- NCT number
- NCT03044353
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Amyloidosis
- Interventions
- GSK2315698 (CPHPC), GSK2398852 (anti-SAP mAb)
- First posted
- 2017-02-07
- Last updated
- 2019-10-16
- Other registries' IDs
- eudract:2016-000276-23
- Results first posted
- 2019-10-16
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-up | Left ventricular mass was measured by Cardiac Magnetic Resonance (CMR) imaging to assess reduction in cardiac amyloid load after repeated administration of anti-SAP treatment. Each CMR imaging session took approximately 45-60 minutes, with a maximum scan time inside of the scanner of 90 minutes. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Safety Population comprised of all participants who received at least one dose of study treatment (any dose of CPHPC \[GSK2315698\] or anti-SAP mAb \[GSK2398852\]). |
| Primary | Number of Participants With Any On-treatment Adverse Events (AEs) | Up to 56 days after the last dosing session (up to 265 days) | AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any on-treatment AEs are presented. |
| Primary | Number of Participants With Any Serious Adverse Events (SAEs) | Up to the end of study (Up to 369 days) | AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAEs during study are presented. |
| Primary | Number of Participants With Abnormal Hematology Values | Up to the end of study (Up to 369 days) | Blood samples were collected for assessment of hematology parameters, which included platelet count, hemoglobin, hematocrit, erythrocytes, reticulocyte count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, leukocytes and basophils. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories. |
| Primary | Number of Participants With Abnormal Clinical Chemistry Values | Up to the end of study (Up to 369 days) | Blood samples were collected for assessment of clinical chemistry parameters, which included aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), urea, creatinine, glucose, chloride, creatinine kinase, potassium, sodium, calcium, total carbon dioxide (CO2), urate, total and direct bilirubin, total protein and albumin. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories. |
| Primary | Number of Participants With Abnormal Urinalysis Results | Up to the end of study (Up to 369 days) | Urine samples were collected to assess potential of hydrogen (pH), specific gravity, albumin excretion rate, creatinine excretion rate and protein excretion rate. Abnormal urinalysis results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories. |
| Primary | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Up to the end of study (Up to 369 days) | Urine samples were collected to assess character parameters which included Cellular Casts, Erythrocytes, Glucose, Ketones, Leukocytes and Occult Blood. Number of participants with abnormal urinalysis results are presented. Data for worst case post Baseline is presented. |
| Primary | Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria | Up to the end of study (Up to 369 days) | Vital signs including body temperature was measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in body temperature from Baseline to worst case post Baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for body temperature was: high: \>37.5 degree Celsius; low: not applicable. |
| Primary | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | Up to the end of study (Up to 369 days) | Vital signs including SBP and DBP were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in SBP and DBP from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for SBP was: high: \>180 millimeter of mercury (mmHg); low: \<90 mmHg. PCI criteria for DBP was: high: \>110 mmHg; low: \<30 mmHg. |
| Primary | Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria | Up to the end of study (Up to 369 days) | Vital signs including pulse rate were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in pulse rate from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to its PCI criteria. PCI criteria for pulse rate was: high: \>140 beats per minute (bpm); low: \<35 bpm. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-up | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Grams | MEAN |
| PRIMARY | Number of Participants With Any On-treatment Adverse Events (AEs) | Up to 56 days after the last dosing session (up to 265 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Serious Adverse Events (SAEs) | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Hematology Values | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinical Chemistry Values | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Urinalysis Results | Up to the end of study (Up to 369 days) | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Up to the end of study (Up to 369 days) | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group1,555
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Session 2, Day 24, n=6,0 | 2.505 | Standard Deviation 19.9174 | Grams |
| Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Session 3, Day 24, n=6,0 | 4.175 | Standard Deviation 22.9366 | Grams |
| Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Session 4, Day 24, n=5,0 | 9.194 | Standard Deviation 14.4271 | Grams |
| Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Session 5, Day 24, n=4,0 | 7.955 | Standard Deviation 19.4341 | Grams |
| Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 8 Weeks Follow up, n=6,1 | 0.977 | Standard Deviation 12.1795 | Grams |
| Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Group 2: Post-chemotherapy AL Amyloidosis Participants | 8 Weeks Follow up, n=6,1 | -32.420 | Standard Deviation NA | Grams |
| Number of Participants With Any On-treatment Adverse Events (AEs) | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 6 | Participants | ||
| Number of Participants With Any On-treatment Adverse Events (AEs) | Group 2: Post-chemotherapy AL Amyloidosis Participants | 1 | Participants | ||
| Number of Participants With Any Serious Adverse Events (SAEs) | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 2 | Participants | ||
| Number of Participants With Any Serious Adverse Events (SAEs) | Group 2: Post-chemotherapy AL Amyloidosis Participants | 1 | Participants |
1 to 10 of 1,555Source ClinicalTrials.gov
See all 1,555 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 6 | |
| Overall Study | STARTED | Group 2: Post-chemotherapy AL Amyloidosis Participants | 1 | |
| Overall Study | STARTED | Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants | 0 | |
| Overall Study | COMPLETED | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 6 | |
| Overall Study | COMPLETED | Group 2: Post-chemotherapy AL Amyloidosis Participants | 0 | |
| Overall Study | COMPLETED | Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants | 0 | |
| Overall Study | NOT COMPLETED | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 0 | |
| Overall Study | NOT COMPLETED | Group 2: Post-chemotherapy AL Amyloidosis Participants | 1 | |
| Overall Study | NOT COMPLETED | Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants | 0 |
Source ClinicalTrials.gov
Adverse events152
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 3 | 6 | 5 |
| other | Constipation | Gastrointestinal disorders | Group 2: Post-chemotherapy AL Amyloidosis Participants | 1 | 1 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 2 | 6 | 2 |
| other | Dyspepsia | Gastrointestinal disorders | Group 2: Post-chemotherapy AL Amyloidosis Participants | 0 | 1 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 1 | 6 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Group 2: Post-chemotherapy AL Amyloidosis Participants | 0 | 1 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 1 | 6 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Group 2: Post-chemotherapy AL Amyloidosis Participants | 0 | 1 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 1 | 6 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Group 2: Post-chemotherapy AL Amyloidosis Participants | 0 | 1 | 0 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 0 | 6 |
| Total, all-cause mortality | Group 2: Post-chemotherapy AL Amyloidosis Participants | 0 | 1 |
| Total, other adverse events | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 6 | 6 |
| Total, other adverse events | Group 2: Post-chemotherapy AL Amyloidosis Participants | 1 | 1 |
| Total, serious adverse events | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | 2 | 6 |
| Total, serious adverse events | Group 2: Post-chemotherapy AL Amyloidosis Participants | 1 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants vs Group 2: Post-chemotherapy AL Amyloidosis Participants: Number of Participants With Any Serious Adverse Events (SAEs) | Trial comparisons |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants vs Group 2: Post-chemotherapy AL Amyloidosis Participants: Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies | Trial comparisons |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants vs Group 2: Post-chemotherapy AL Amyloidosis Participants: Number of Participants With Skin Rashes | Trial comparisons |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants vs Group 2: Post-chemotherapy AL Amyloidosis Participants: Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies | Trial comparisons |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants vs Group 2: Post-chemotherapy AL Amyloidosis Participants: Number of Participants With Any On-treatment Adverse Events (AEs) | Trial comparisons |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants vs Group 2: Post-chemotherapy AL Amyloidosis Participants: deaths from any cause | Trial comparisons |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants vs Group 2: Post-chemotherapy AL Amyloidosis Participants: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03044353
GET https://conductscience.org/api/trials/v1/NCT03044353/registered?page=2